Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT07223242

Tailored Exercise Training Study Among Adults With HFpEF

Led by University of Texas Southwestern Medical Center · Updated on 2025-10-31

120

Participants Needed

1

Research Sites

97 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Heart failure with preserved ejection fraction (HFpEF) is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers. This study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with HFpEF, or those at risk for it. In addition, it will compare four different lifestyle interventions for their effects on exercise capacity.

CONDITIONS

Official Title

Tailored Exercise Training Study Among Adults With HFpEF

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Left ventricular ejection fraction (LVEF) 50% or higher
  • History of HFpEF or at risk for HFpEF, defined by hospitalization for HF within 12 months or elevated NT-proBNP >360 pg/mL
  • At risk for HFpEF with more than 2 risk factors such as diabetes, hypertension, obesity, or physical inactivity
  • Short Physical Performance Battery (SPPB) score less than 10 or peak oxygen uptake below the 60th percentile
  • Body mass index (BMI) of 28 or higher for Phase II randomization
  • Ability to use a cell phone and mobile application
Not Eligible

You will not qualify if you...

  • Hospitalization within 1 month before baseline visit
  • History of recurrent falls
  • Estimated glomerular filtration rate (eGFR) below 20 ml/min/1.73m
  • Recent changes in heart failure treatments within 2 weeks before baseline visit
  • Unable to participate in exercise training therapy
  • Unable to perform cardiopulmonary exercise testing (CPET)
  • Severe left-sided valvular heart disease
  • End-stage pulmonary disease requiring continuous supplemental oxygen
  • Major surgery within 3 months of screening or planned during the study
  • Unstable weight with more than 5% change in the last 30 days before the first study visit
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75209

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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